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Drug Catalog - Product Detail

CLOBETASOL PROPIONATE GEL GEL 0.0005 15GM

NDC Mfr Size Str Form
45802-0925-14 PADAGIS 15 0.05% NA
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Description
DESCRIPTION Clobetasol Propionate Gel, 0.05% contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Chemically, clobetasol propionate is (11ß,16ß)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)-pregna-1,4-diene-3,20-dione, and it has the following structural formula: Clobetasol propionate has the empirical formula C25H32ClFO5 and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water. Clobetasol Propionate Gel, 0.05% contains clobetasol propionate 0.5 mg/g in a base of carbomer homopolymer type B, propylene glycol, purified water, and sodium hydroxide. image description
How Supplied
HOW SUPPLIED Clobetasol Propionate Gel, 0.05% is available as follows: 15 g tube (NDC 45802-925-14) 30 g tube (NDC 45802-925-94) 60 g tube (NDC 45802-925-96)
Indications & Usage
INDICATIONS AND USAGE Clobetasol Propionate Gel, 0.05% is a super-high potency corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended.
Dosage and Administration
DOSAGE AND ADMINISTRATION Apply a thin layer of Clobetasol Propionate Gel, 0.05% to the affected skin areas twice daily and rub in gently and completely (see INDICATIONS AND USAGE ). Clobetasol Propionate Gel, 0.05% is a super-high potency topical corticosteroid; therefore, treatment should be limited to 2 consecutive weeks and amounts greater than 50 g/week should not be used. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Clobetasol Propionate Gel, 0.05% should not be used with occlusive dressings.